Process Validation Engineer

Process Validation Engineer

Job Summary

We are seeking a Process Validation Engineer to join our team in Austin, Texas. Reporting to the Validation Quality Manager, this role is responsible for equipment validation to ensure compliance with internal policies, procedures, and regulatory requirements for medical device manufacturing.

Key Responsibilities (include but are not limited to):

• Define qualification requirements and lead equipment and process validation activities to completion.
• Provide oversight for equipment qualification (IQ, OQ, TMV, PQ) and ensure compliance with regulatory and internal standards.
• Author, execute, and/or review validation plans, protocols, reports, risk assessments, traceability matrices, and change control documentation.
• Monitor validation activities to ensure adherence to approved procedures and maintain complete, accurate documentation.
• Collaborate with crossfunctional teams and customers on technical, quality, and continuous improvement initiatives.
• Make informed, independent decisions regarding validation approaches and technical issues.
• Evaluate alternative methods and propose solutions to meet operational and compliance needs.
• Support facilities validation and quality engineering projects as required by business needs.

Requirements

• Bachelor's degree in Engineering, Science, or a related field, with 5-6 years of experience in the medical device, pharmaceutical, or biotechnology industries.
• Strong working knowledge of applicable regulatory and quality standards, including CFR Part 820, Part 11, ISO 13485, ISO 9001, Annex 11, and GAMP.
• Proven hands-on experience with manufacturing equipment validation, including developing and executing IQ/OQ/PQ/TMV and performing statistical analysis.
• Demonstrated ability to generate, review, and approve validation documentation such as protocols, reports, risk assessments, and change control records.
• Ability to work independently, manage multiple priorities, and make sound technical decisions with minimal supervision.
• Strong communication, organization, and problemsolving skills.
• Experience with Facilities validation working in a 24/7 operations environment is strongly preferred.

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Advantage Technical is an equal opportunity employer. All applicants will receive consideration without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status, or any other legally protected status. Advantage Technical offers reasonable accommodations for qualified individuals with disabilities; contact your local branch for inquiries. Advantage Technical is an E-Verify employer. See our Privacy Notice for Candidates and Employees/Contractors at https://smgroupna.com/privacy-notice-for-candidates-and-employees-contractors. By applying, you consent to receive AI-generated and non-AI-generated calls, texts, or emails from Staffmark Group, its affiliates, and partners. Frequency varies and message/data rates may apply. Reply STOP to cancel or HELP for help.